HHS Secretary Sebelius Overrules FDA on Plan B

Today Secretary of Health and Human Services Kathleen Sebelius overruled the FDA’s decision to lift the age limit for emergency contraception and permitting the over-the-counter sale of the “morning after pill.” Sebelius indicated that she did “not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age.”

Margaret Hamburg, FDA administrator, stated, “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential. However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.”

Dr. Susan Wood, who resigned from the FDA over the Bush Administration’s decision to Plan B and is currently the former FDA Assistant Commissioner for Women’s Health and associate professor of Health Policy and Director of the Jacobs Institute at the GW School of Public Health and Health Services, issued the following statement: “This decision is stunning. I had come to believe that the FDA would be allowed to make decisions based on science and the public’s health. Sadly, once again, FDA has been over-ruled and not allowed to do its job. I cannot understand why Secretary Sebelius would reach in and overturn the FDA’s decision to allow timely access for all those who need safe and effective emergency contraception.”

“We are outraged that this Administration has let politics trump science. There is no rationale for this move. This is unprecedented as evidenced by the Commissioner’s own letter. Unbelievable,” says Kirsten Moore, President and CEO of the Reproductive Health Technologies Project.

Levonorgestrel, sold under the brand name Plan B, is a form of emergency contraception that must be taken within 72 hours of sexual activity. Emergency contraception or the “morning-after” pill is available behind the counter without a prescription to women over the age of 17 in the United States. Girls 16 years and younger are required to have a doctor’s prescription.